Cooper Surgical, Inc.
Complete recall history across all FDA and CPSC categories — 13 total recalls
Cooper Surgical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (13)
FDA medical device enforcement actions by Cooper Surgical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... | Incorrect size was printed on the outer product packaging. | Class II |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Proc... | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) h... | Class II |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... | Pessary mislabeled outer package may not reflect the size of the product cont... | Class III |
| Oct 31, 2012 | Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: U... | Excessive pressure exerted on the uterine tip when attached to the Arch may,... | Class II |
| Oct 31, 2012 | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 ... | Excessive pressure exerted on the uterine tip when attached to the Arch may,... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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